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← See all Guaifenesin and Dextromethorphan Hydrobromide brands

Guaifenesin and Dextromethorphan Hydrobromide

Medically reviewed on October 16, 2017

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg, DEXTROMETHORPHAN HYDROBROMIDE 60mg
Labeler: OHM LABORATORIES INC
NDC Code: 51660-073

Guaifenesin 1200 mg Extended-Release Tablets & Dextromethorphan HBr 60 mg

Drug Facts

Active ingredients (in each extended-release tablet)Purposes

Dextromethorphan HBr 60 mg

Cough suppressant

Guaifenesin 1200 mg

Expectorant

Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep

Warnings

Do not use
for children under 12 years of age
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

When using this product
do not use more than directed

Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions
do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age: do not use

Other information
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Made in England

PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack Carton

Compare To
the active ingredients of
Maximum Strength
Mucinex® DM

NDC 51660-073-86

ohm®

Maximum Strength
Guaifenesin 1200 mg
& Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant & Cough Suppressant

12 Hour

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

28 Extended-Release Tablets

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-073
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains    
Packaging
#Item CodePackage Description
1NDC:51660-073-541 BLISTER PACK in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:51660-073-862 BLISTER PACK in 1 CARTON
214 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162012/10/2017
Labeler - OHM LABORATORIES INC (184769029)
Establishment
NameAddressID/FEIOperations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-073)

 
OHM LABORATORIES INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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